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A Phase 1/2 Study of [225Ac]-FPI-1434 Injection
This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of \[225Ac\]-FPI-1434 (radioimmuno-therapeutic agent) in patients with solid tumours that demonstrate uptake of \[111In\]-FPI-1547 (radioimmuno-imaging agent), and to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of repeat doses of \[225Ac\]-FPI-1434 Injection in patients with solid tumours that demonstrate uptake of \[111In\]-FPI-1547 (radioimmuno-imaging agent).
Study details:
This study consists of a Phase 1 portion and a Phase 2 portion. Phase 1 includes the following cohorts: Single dose-ascending cohorts and Multi- dose ascending cohorts of \[225Ac\]-FPI-1434 and Multi- dose ascending cohorts evaluating administration of FPI-1175 (cold antibody), followed by, \[225Ac\]-FPI-1434 (cold + hot), with cycles repeating every 42 days. And Cold Antibody Sub-study evaluating administration of ascending doses of FPI-1175 followed by \[111In\]-FPI-1547.
The Phase 2 will evaluate \[111In\]-FPI-1547 and \[225Ac\]-FPI-1434 with or without FPI-1175 in tumour-specific cohorts. The decision to utilize FPI-1175 in the Phase 2 portion of the study will be determined based on Phase 1 data, including safety, tolerability, pharmacokinetic and dosimetry results.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2019-01-17
Primary completion: 2025-06-01
Study completion finish: 2026-06-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT03746431
Intervention or treatment
DRUG: [111In]-FPI-1547 Injection
DRUG: [225Ac]-FPI-1434 Injection multi-dose
BIOLOGICAL: FPI-1175 Infusion
DRUG: [225Ac]-FPI-1434 Injection single-dose
Conditions
- • Ovarian Cancer
- • Advanced Solid Tumours
- • Endometrial Cancer
- • Cervical Cancer
- • Breast Cancer
- • Triple Negative Breast Cancer (TNBC)
- • HER2-negative Breast Cancer
- • Head and Neck Squamous Cell Carcinoma (HNSCC)
- • Adrenocortical Carcinoma
- • Uveal Melanoma
Find a site
Closest Location:
Royal Adelaide Hospital
Research sites nearby
Select from list below to view details:
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: [225Ac]-FPI-1434 Single-Dose Escalation
| DRUG: [111In]-FPI-1547 Injection
|
EXPERIMENTAL: [225Ac]-FPI-1434 Multi-Dose Escalation
| DRUG: [111In]-FPI-1547 Injection
|
EXPERIMENTAL: FPI-1175 Cold Antibody
| DRUG: [111In]-FPI-1547 Injection
|
EXPERIMENTAL: [225Ac]-FPI-1434 Multi-Dose
| DRUG: [111In]-FPI-1547 Injection
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Dose Escalation: Incidence of adverse events (AEs). | Phase 1 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
Single-Dose Escalation: Incidence of dose limiting toxicities (DLTs). | Phase 1 | 8 weeks. |
Multi-Dose Escalation: Incidence of DLTs. | Phase 1 | 6 weeks. |
Dose Escalation: Incidence of clinically significant clinical laboratory abnormalities. | Phase 1 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
Dose Escalation: Changes in electrocardiogram (ECG) parameters (PR, QRS, QT, and QTc intervals). | Phase 1 | 4 weeks post final [225Ac]-FPI-1434 Injection. |
Cold Antibody Sub-Study: Changes in uptake of [111In]-FPI-1547 Injection following FPI-1175 Infusion in selected regions of interest on SPECT/CT images. | Phase 1 | Within two weeks of the first [111In]-FPI-1547 Injection. |
Cold Antibody Sub-Study: Changes in radiation dose estimates for selected tissues, organs and whole body both for [111In]-FPI-1547 and [225Ac]-FPI-1434 Injection at various dose levels following FPI-1175 Infusion. | Phase 1 | Within two weeks of the first [111In]-FPI-1547 Injection. |
Evaluate anti-tumour activity of [225Ac]-FPI-1434 regimen | Phase 2 | Approximately one year post final [225Ac]-FPI-1434 injection. |
Objective response rate (ORR) RECIST v1.1. | Phase 2 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Dose Escalation and Cold Antibody Sub-Study: Tumour uptake of [111In]-FPI-1547 in selected regions of interest on SPECT/CT images. | Phase 1 and 2 | Dose Escalation: Within one week of the [111In]-FPI-1547 Injection. Cold-Antibody Sub-Study: Within two weeks of the first [111In]-FPI-1547 Injection. |
Dose Escalation: Radiation doses for selected organs and whole body both for [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection. | Phase 1 and 2 | Within one week of the [111In]-FPI-1547 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Changes in radiation absorbed doses for tumour lesions for [225Ac]-FPI-1434. | Phase 1 and 2 | Dose Escalation: Within one week of the [111In]-FPI-1547 Injection. Cold-Antibody Sub-Study: Within two weeks of the first [111In]-FPI-1547 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Clearance for radioactivity and for the targeting antibody. | Phase 1 and 2 | 4 weeks post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Area under the curve (AUC) for radioactivity and for the targeting antibody. | Phase 1 and 2 | 4 weeks post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Cmax for radioactivity and for the targeting antibody. | Phase 1 and 2 | 4 weeks post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Half-life for radioactivity and for the targeting antibody. | Phase 1 and 2 | 4 weeks post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Objective response rate (ORR) (sum of complete and partial response) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Prostate Cancer Working Group 3 (PCWG3) guidelines. | Phase 1 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
Dose Escalation: Changes in the corrected QT (QTc) interval in milliseconds after [225Ac]-FPI-1434 treatment, compared to baseline. | Phase 1 and 2 | Approximately 24 hours from the time of [225Ac]-FPI-1434 Injection administration. |
Dose Escalation and Cold-Antibody Sub-Study: Changes in human growth hormone (hGh) following [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection. | Phase 1 and 2 | 4 weeks post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Changes in insulin-like growth factor 1 (IGF-1) following [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection. | Phase 1 and 2 | 4 weeks post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Changes in insulin-like growth factor binding protein 3 (IGFBP-3) following [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection. | Phase 1 and 2 | 4 weeks post final [225Ac]-FPI-1434 Injection. |
Cold Antibody Sub-Study: Incidence of AEs. | Phase 1 and 2 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
Cold Antibody Sub-Study: Incidence of clinically significant clinical laboratory abnormalities. | Phase 1 and 2 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
Cold Antibody Sub-Study: Changes in ECG parameters (PR, QRS, QT, and QTc intervals). | Phase 1 and 2 | 4 weeks post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Time to response (TTR). | Phase 1 and 2 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Duration of response (DoR). | Phase 1 and 2 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Progression free survival (PFS). | Phase 1 and 2 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Time to Progression (TTP). | Phase 1 and 2 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Disease control rate (DCR). | Phase 1 and 2 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
Dose Escalation and Cold-Antibody Sub-Study: Overall survival (OS). | Phase 1 and 2 | Approximately one year post final [225Ac]-FPI-1434 Injection. |
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